TECNOZOL 20 mg Tabletki Powlekane

Treść ulotki

1. Tecnozol 20 mg gastro-resistant tablets
   1. What Tecnozol is and what it is used for
   2. What you need to know before taking Tecnozol
2. Tecnozol because it presents an increased risk of developing gastric and
   1. How to take Tecnozol
   2. Possible side effects
   3. How to store Tecnozol
   4. Contents of the pack and other information
3. Tecnozol 40 mg gastro-resistant tablets
   1. What Tecnozol is and what it is used for
   2. What you need to know before taking Tecnozol
   3. What you need to know before taking Tecnozol
   4. Possible side effects
   5. How to store Tecnozol
   6. Contents of the pack and other information

Tecnozol 20 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start taking this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Tecnozol is and what it is used for
• 2. What you need to know before you take Tecnozol
• 3. How to take Tecnozol
• 4. Possible side effects
• 5. How to store Tecnozol
• 6. Contents of the pack and other information

1. What Tecnozol is and what it is used for

Tecnozol contains the active substance pantoprazole. Tecnozol is a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine. Tecnozol is used for the treatment of adults and adolescents of 12 years and over for

• Symptoms (e.g. heartburn, acid regurgitation, pain when swallowing) associated with gastroesophageal reflux disease caused by acid reflux from the stomach.
• Long-term treatment of reflux esophagitis (inflammation of the esophagus accompanied by acid regurgitation from the stomach) and prevention of its recurrence.

Tecnozol is used for the treatment of adults for

• Prevention of duodenal and stomach ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs, for example, ibuprofen) in patients at risk who require continuous treatment with NSAIDs.

2. What you need to know before taking Tecnozol

Do not take Tecnozol
If you are allergic to pantoprazole or any of the other ingredients of this medicine
(listed in section 6);
If you are allergic to other medicines containing proton pump inhibitors;

Warnings and precautions
Tell your doctor, pharmacist or nurse before taking Tecnozol:
if you suffer from severe liver problems. Tell your doctor if you have ever had liver problems. The
doctor will arrange more frequent monitoring of your liver enzymes, especially if you are
taking Tecnozol for long-term therapy. If liver enzymes increase
treatment should be discontinued.
If you need continuous treatment with medicines called NSAIDs and you are taking

Tecnozol because it presents an increased risk of developing gastric and

intestinal complications. Each increased risk will be evaluated based on your personal risk factors
such as age (65 years and over), a history of gastric or duodenal ulcers or gastrointestinal bleeding.
If you have reduced body reserves or risk factors for reduced vitamin B12 and are undergoing
long-term treatment with pantoprazole. As with all agents that reduce
acidity, pantoprazole may lead to reduced absorption of vitamin B12. If
you are simultaneously taking HIV protease inhibitors such as atazanavir (for the treatment of HIV infection) with pantoprazole, ask your doctor for specific advice
Taking a proton pump inhibitor such as pantoprazole, especially for a period
longer than one year, may slightly increase the risk of fractures of the hip, wrist or
spine. Tell your doctor if you have osteoporosis or are taking
corticosteroids (which may increase the risk of osteoporosis).
If you have been taking Tecnozol for more than three months, the levels of magnesium in your
blood may decrease. Low levels of magnesium can cause fatigue, involuntary
muscle contractions, confusion, seizures, dizziness, increased heart rate. Tell your doctor immediately if you experience any of these symptoms. Low levels
of magnesium can also lead to a reduction in potassium or calcium levels in the blood.
The doctor may decide to perform regular blood tests to monitor your levels of
magnesium.
if you have ever had a skin reaction after treatment with a medicine similar to
Tecnozol that reduces gastric acidity.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact your
doctor as soon as possible, as you may need to stop therapy
with Tecnozol. Also remember to report any other undesirable effects such as joint pain.
if you need to undergo a specific blood test (Chromogranin A)
Immediately inform your doctor, before or after taking this medicine, if you notice any of the
following symptoms that may be a sign of a more serious illness:

• unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit, which may appear as dark coffee grounds in the vomit
• appearance of blood in the stool which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appears pale or feels weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignancy
because pantoprazole also relieves the symptoms of cancer and may cause a delay
in diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Tecnozol for long-term treatment (more than 1 year), your doctor will likely
monitor you regularly. You should report any new or
exceptional symptom or circumstance whenever you see your doctor.

Children and adolescents
Tecnozol is not recommended for use in children given that its efficacy has not been demonstrated
in children under 12 years of age.

Other medicines and Tecnozol
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.
Tecnozol can affect the effectiveness of other medicines, so tell your doctor if you are
taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Tecnozol may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood thickening or dilution. You may need further checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily suspend treatment with Tecnozol because pantoprazole may increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
There are no adequate data regarding the use of pantoprazole in pregnant women. It has been
reported excretion in human milk.
In case of pregnancy or breastfeeding, or if you think you may be pregnant, or
are planning a pregnancy, ask your doctor or pharmacist for advice before taking this
medicine.
You should only take this medicine if the doctor believes that the benefit is greater than the
potential risk to the fetus or newborn.

Driving and using machines
Tecnozol does not alter or negligibly alters the ability to drive vehicles and use
machinery.
If side effects such as dizziness or visual disturbances occur, you should not drive or use
machinery.

3. How to take Tecnozol

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Method of administration:
Take the tablets 1 hour before meals without chewing or crushing them and swallow them whole
with some water.
The recommended dose is:

Adults and adolescents 12 years and over

• For the treatment of symptoms associated with gastroesophageal reflux disease (e.g. heartburn, acid regurgitation, pain when swallowing) The usual dose is one tablet a day. This dose normally provides relief in 2 - 4 weeks - at most after another 4 weeks. The doctor will tell you how long to continue taking the medicine. After this, any recurrence of symptoms can be controlled by taking one tablet a day, as needed.
• For long-term treatment and prevention of recurrent reflux esophagitis The usual dose is one tablet a day. If the disease recurs, the doctor may double the dose, in which case you may instead use Tecnozol 40 mg tablets, one a day. After healing, the dose can be reduced back to one 20 mg tablet a day.

Adults

• For the prevention of duodenal and gastric ulcers in patients who require continuous treatment with NSAIDs The usual dose is one tablet a day.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet a day.

Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

If you take more Tecnozol than you should
Consult your doctor or pharmacist. No symptoms of overdose are known.

If you forget to take Tecnozol
Do not take a double dose to make up for the missed tablet. Take the normal
dose at the next scheduled time.

If you stop taking Tecnozol
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects, stop taking these tablets and
immediately inform your doctor or contact the emergency room of the nearest hospital.

• Serious allergic reactions (rare frequency: may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Serious skin conditions (frequency not known: frequency cannot be defined on the basis of available data):skin blisters and rapid deterioration of your general condition, erosions (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known):yellowing of the skin or whites of the eyes (serious damage to liver cells, jaundice) or fever, skin rashes and enlargement of the kidneys sometimes with painful urination and back pain (serious kidney inflammation) which may lead to possible kidney failure.

Other side effects are:

Common(may affect up to 1 in 10 people):
Benign polyps in the stomach

Uncommon(may affect up to 1 in 100 people):
headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence;
constipation; dry mouth; abdominal pain and discomfort; skin irritation, rash, skin eruption
pruritus; feeling of weakness, fatigue or general malaise; sleep disorders;
hip, wrist or spine fracture.

Rare(may affect up to 1 in 1,000 people):
Alteration or complete loss of the sense of taste; visual disturbances such as blurred vision;
hives; joint pain; muscle pain; weight changes; increased
body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions;
depression; breast enlargement in men;

Very rare(may affect up to 1 in 10,000)
disorientation,

Not known(frequency cannot be established on the basis of available data):
Hallucinations, confusion (especially in patients with a history of these symptoms);
decreased sodium levels in the blood, decreased magnesium levels in the blood
(see section 2), sensation of tingling, pins and needles, burning or
numbness, erythema, possible joint pain.

Side effects identified through blood tests:
Uncommon(may affect up to 1 in 100)
increased liver enzymes.

Rare(may affect up to 1 in 1,000)
increased bilirubin; increased fats in the blood; drastic decrease in circulating granulocytes,
associated with high fever.

Very rare(may affect up to 1 in 10,000)
reduction in the number of platelets in the blood, which can cause bleeding or bruising
more than normal; reduction in the number of white blood cells, which can lead to more
frequent infections; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as
platelets.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
inform your doctor or pharmacist. You can also report side effects directly
through the national reporting system at www.aifa.gov.it/content/segnalazioni-
reazioni-avverse.

5. How to store Tecnozol

Keep this medicine out of sight and reach of children.
Store at a temperature below 30ºC.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tecnozol contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 20 mg of pantoprazole (as pantoprazole sodium sesquihydrate)
• The other ingredients are: anhydrous disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium starch glycolate (Type A), methacrylic acid-ethyl acrylate copolymer (1:1) and yellow iron oxide (E172).

Description of the appearance of Tecnozol and contents of the pack
Tecnozol gastro-resistant tablets 20 mg are oval in shape, yellow in colour,
biconvex, smooth. The dimensions of the tablet are as follows:

• Width: 5.85 mm ± 0.29 mm (5.56 mm - 6.14 mm)
• Length: 8.35 mm ± 0.42 mm (7.93 mm - 8.77 mm)

Tecnozol is available in blister packs of 14, 28, 56, and 100 gastro-resistant tablets. Not all pack sizes may be marketed.

Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
Teva Pharma S.L.U.
C/C. no 4, Poligono Industrial Malpica
50016 Zaragoza
Spain

Exclusive distributor for sale in Italy:
Farma Group S.r.l.
Via Strampelli, 18

• 63074- San Benedetto del Tronto (AP)

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:

Tecnozol 40 mg gastro-resistant tablets

Generic medicine

Read this leaflet carefully before you start to take this medicine because
it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What Tecnozol is and what it is used for
• 2. What you need to know before you take Tecnozol
• 3. How to take Tecnozol
• 4. Possible side effects
• 5. How to store Tecnozol
• 6. Contents of the pack and other information

1. What Tecnozol is and what it is used for

Tecnozol contains the active ingredient pantoprazole. Tecnozol is a selective “proton pump inhibitor”, a medicine that reduces the amount of acid produced in the stomach. It is used for the treatment of acid-related diseases of the stomach and intestine. Tecnozol is used for the treatment of adults and adolescents of 12 years and older for

• Reflux esophagitis. An inflammation of the esophagus (the tube that connects the throat to the stomach) accompanied by acid reflux. Tecnozol is used for the treatment of adults for
• An infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (eradication therapy). The purpose is to get rid of the bacteria in order to reduce the possibility that these ulcers will return.
• Ulcers of the stomach and duodenum.
• Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach

2. What you need to know before taking Tecnozol

Do not take Tecnozol
if you are allergic to pantoprazole or any of the other ingredients of this medicine
(listed in section 6)
if you are allergic to medicines containing proton pump inhibitors

Warnings and precautions
Tell your doctor, pharmacist or nurse before taking Tecnozol:
if you have severe liver problems. Tell your doctor if you have ever had liver problems. The
doctor will arrange for more frequent monitoring of your liver enzymes, especially if you are
taking Tecnozol for long-term therapy. If liver enzymes increase
treatment should be discontinued.
If you have reduced body reserves or risk factors for reduced vitamin B12 and are undergoing
long-term treatment with pantoprazole. As with all agents that reduce
acidity, pantoprazole can lead to reduced absorption of vitamin B12.
If you are simultaneously taking HIV protease inhibitors
such as atazanavir (for the treatment of HIV infection), ask your doctor for advice
specific.
Taking a proton pump inhibitor such as pantoprazole, especially for a period
longer than one year, may slightly increase the risk of fractures of the hip, wrist or
spine. Tell your doctor if you have osteoporosis or are taking
corticosteroids (which can increase the risk of osteoporosis).
If you have been taking Tecnozol for more than three months, the levels of magnesium in your
blood may decrease. Low levels of magnesium can cause fatigue, involuntary
muscle contractions, disorientation, convulsions, dizziness, increased heart rate.
Tell your doctor immediately if you experience any of these symptoms. Low levels
of magnesium can also lead to a reduction in potassium or calcium levels in the blood.
The doctor may decide to perform regular blood tests to monitor your levels of
magnesium.
if you have ever had a skin reaction after treatment with a medicine similar to
Tecnozol that reduces stomach acid.
If you notice the appearance of a skin rash, especially in areas exposed to sunlight, contact
your doctor as soon as possible, as it may be necessary to stop therapy
with Tecnozol. Remember to also report any other unwanted effects such as joint pain.
if you are to undergo a specific blood test (Chromogranin A)
Tell your doctor immediately before or after taking this medicine if you notice any of the
following symptoms that may be a sign of a more serious illness:

• an unintentional weight loss
• vomiting, especially if repeated
• presence of blood in the vomit, this may appear as dark coffee grounds in the vomit
• appearance of blood in the stool which may appear dark or tarry
• difficulty swallowing or pain when swallowing
• appears pale or feels weak (anemia)
• chest pain
• stomach pain
• severe and/or persistent diarrhea, as this medicine has been associated with a modest increase in infectious diarrhea.

The doctor may decide that you need to undergo some tests to rule out a malignant disease
because pantoprazole also relieves the symptoms of cancer and may cause a delay
in diagnosis. If your symptoms persist despite treatment, further investigations should be considered.
If you take Tecnozol for long-term treatment (more than 1 year) your doctor will probably
keep you under regular control. You should report any new or
exceptional symptom or circumstance whenever you meet your doctor.

Children and adolescents
Tecnozol is not recommended for use in children as its efficacy has not been demonstrated
in children under 12 years of age.

Other medicines and Tecnozol
Tell your doctor or pharmacist if you are taking, have recently taken or might
take any other medicines, including over-the-counter medicines.
This is because Tecnozol can affect the effectiveness of other medicines, so tell your doctor if
you are taking:

• Medicines such as ketoconazole, itraconazole and posaconazole (used to treat fungal infections) or erlotinib (used for some types of cancer) because Tecnozol may prevent these and other medicines from working properly.
• Warfarin and phenprocoumon, which affect blood clotting or thinning. You may need further checks.
• Medicines used to treat HIV infection, such as atazanavir.
• Methotrexate (used to treat rheumatoid arthritis, psoriasis and cancer) - if you are taking methotrexate, your doctor may temporarily stop treatment with Tecnozol because pantoprazole can increase methotrexate levels in the blood.
• Fluvoxamine (used to treat depression and other psychiatric illnesses) - if you are taking fluvoxamine your doctor may reduce the dose.
• Rifampicin (used to treat infections).
• St John's Wort (Hypericum perforatum) (used to treat mild depression).

Pregnancy and breastfeeding
There is no adequate data regarding the use of pantoprazole in pregnant women. It has been
reported excretion in human milk.
If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning
a pregnancy, ask your doctor or pharmacist for advice before taking this medicine.
You should only take this medicine if your doctor believes that the benefit is greater than the
potential risk to the fetus or newborn.

Driving and using machines
Tecnozol does not alter or negligibly alters the ability to drive vehicles and use
machinery.
If side effects such as dizziness or visual disturbances occur, you should not drive or use
machinery.

3. What you need to know before taking Tecnozol

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Method of administration:
Take the tablets 1 hour before meals without chewing or crushing them and swallow them whole
with a little water.
The recommended dose is:

Adults and adolescents 12 years and over

• For the treatment of reflux esophagitis, the usual dose is one tablet a day. Your doctor may tell you to increase the dose to 2 tablets a day. The treatment period for reflux esophagitis is usually between 4 and 8 weeks. Your doctor will tell you how long to take the medicine.

Adults

• For the treatment of an infection with a bacterium called Helicobacter pylori in patients with duodenal ulcer and gastric ulcer in combination with two antibiotics (Eradication therapy). One tablet, twice a day plus two tablets of an antibiotic between amoxicillin, clarithromycin and metronidazole (or tinidazole), each taken twice a day with the pantoprazole tablet. Take the first pantoprazole tablet 1 hour before breakfast and the second pantoprazole tablet 1 hour before the evening meal. Follow your doctor's instructions and

one or two weeks.

• For the treatment of gastric and duodenal ulcers. The usual dose is one tablet a day. After consulting your doctor, the dose may be doubled. Your doctor will tell you how long to take the medicine. The treatment period for gastric ulcers is typically between 4 and 8 weeks. The treatment period for duodenal ulcers is typically between 2 and 4 weeks.
• For the long-term treatment of Zollinger-Ellison syndrome and other conditions in which too much acid is produced in the stomach. The recommended initial dose is usually two tablets a day. Take the two tablets 1 hour before a meal. Your doctor may subsequently adjust the dosage, depending on the amount of gastric acid produced. If more than two tablets are prescribed per day, the tablets must be taken twice a day. If your doctor prescribes a daily dose of more than four tablets a day, you will be told exactly when to stop taking the medicine.

Patients with kidney problems
If you have kidney problems, you should not take Tecnozol for the eradication of Helicobacter pylori.

Patients with liver problems
If you suffer from severe liver problems, you should not take more than one 20 mg tablet of
pantoprazole a day (tablets containing 20 mg of
pantoprazole are available for this purpose).
If you suffer from severe or moderate liver problems, you should not take Tecnozol for the eradication
of Helicobacter Pylori

Use in children and adolescents
These tablets are not recommended for use in children under 12 years of age.

If you take more Tecnozol than you should
Consult your doctor or pharmacist. No symptoms of overdose are known

If you forget to take Tecnozol
Do not take a double dose to make up for a missed dose.
Take the normal next dose at the scheduled time.

If you stop taking Tecnozol
Do not stop treatment with these tablets without first consulting your doctor or
pharmacist.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist or
nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience any of the following side effects, stop taking these tablets and
immediately inform your doctor or contact the nearest hospital emergency room.

• Severe allergic reactions (rare frequency: may affect up to 1 in 1,000 people):swelling of the tongue and/or throat, difficulty swallowing, hives, difficulty breathing, allergic facial swelling (angioedema/Quincke's edema), severe dizziness with a very fast heartbeat and profuse sweating.
• Severe skin conditions (frequency not known: frequency cannot be defined based on available data):skin blisters and rapid deterioration of your general condition, erosion (including mild bleeding) of eyes, nose, mouth/lips or genitals (Stevens-Johnson syndrome, Lyell's syndrome, Multiforme erythema) and light sensitivity.
• Other serious conditions (frequency not known: frequency cannot be defined based on available data):yellowing of the skin or the whites of the eyes (serious damage to liver cells, jaundice) or fever, skin rashes and enlargement of the kidneys sometimes with painful urination and back pain (severe kidney inflammation) which can lead to possible kidney failure.

Other side effects are:

Common(may affect up to 1 in 10 people)
Benign polyps in the stomach

Uncommon(may affect up to 1 in 100 people)
headache; dizziness; diarrhea; feeling unwell, vomiting; bloating and flatulence;
constipation; dry mouth; abdominal pain and discomfort; skin irritation, rash, eruption
on the skin; itching; feeling of weakness, fatigue or general malaise; sleep disorders;
hip, wrist or spine fracture.

Rare(may affect up to 1 in 1,000 people)
Alteration or complete loss of the sense of taste; visual disturbances such as blurred vision;
hives; joint pain; muscle pain; weight changes; increased
body temperature; high fever; swelling of the extremities (peripheral edema); allergic reactions;
depression; breast enlargement in men;

Very rare(may affect up to 1 in 10,000 people)
disorientation.

Not known(frequency cannot be established based on available data):
Hallucinations, confusion (especially in patients with a history of these symptoms);
decreased sodium levels in the blood, decreased magnesium levels in the blood
(see section 2), sensation of tingling, pins and needles, burning or
numbness, erythema, possible joint pain.

Side effects identified through blood tests:
Uncommon(may affect up to 1 in 100 people)
increased liver enzymes.

Rare(may affect up to 1 in 10,000 people):
increased bilirubin; increased fats in the blood; drastic decrease in circulating granulocytes,
associated with high fever.

Very rare(may affect up to 1 in 10,000 people)
reduction in the number of platelets in the blood, which can cause bleeding or bruising
more than normal; reduction in the number of white blood cells, which can lead to more
frequent infections; coexisting abnormal reduction in the number of red blood cells and white blood cells, as well as
platelets.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform
your doctor or pharmacist. You can also report side effects directly through the
national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

5. How to store Tecnozol

Keep this medicine out of sight and reach of children.
Store at a temperature below 30ºC.
Do not use this medicine after the expiry date which is stated on the packaging after "Scad.".
The expiry date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Tecnozol contains

• The active ingredient is pantoprazole. Each gastro-resistant tablet contains 40 mg of pantoprazole (as pantoprazole sesquihydrate)
• The excipients are: anhydrous disodium phosphate, mannitol, microcrystalline cellulose, sodium croscarmellose, magnesium stearate, hypromellose, triethyl citrate, sodium starch glycolate (Type A), ethyl acrylate-methacrylic acid copolymer (1:1) and yellow iron oxide (E172).

Description of the appearance of Tecnozol and contents of the pack
Tecnozol 40 mg gastro-resistant tablets are oval in shape, yellow in colour,
biconvex, smooth.
The dimensions of the tablet are as follows:

• Width: 6.35 mm ± 0.32 mm (6.03 mm - 6.67 mm) Length: 12.00 mm ± 0.60 mm (11.40 mm - 12.60 mm)

Tecnozol is available in blister packs of 7, 14, 28, 56, and 100 gastro-resistant tablets
it is possible that not all pack sizes are marketed.

Marketing Authorisation Holder
Bluefish Pharmaceuticals AB
P.O. Box 49013
100 28 Stockholm
Sweden

Manufacturer
Bluefish Pharmaceuticals AB
Gävlegatan 22
113 30 Stockholm
Sweden
Teva Pharma S.L.U.
C/C. no 4, Poligono Industrial Malpica
50016 Zaragoza
Spain

Exclusive distributor for Italy:
Farma Group S.r.l.
Via Strampelli, 18

• 63074- San Benedetto del Tronto (AP)

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations: